DEVICE: Park 1 (04049584000217)
Device Identifier (DI) Information
Park 1
65000
In Commercial Distribution
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
65000
In Commercial Distribution
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
The PARK 1 combines three measuring functions in one unit.
Auto-Refractometer
An infrared light source projects measuring light onto the retina of the eye
from where it is reflected back to the shutter location. Sensitive sensor
chips, or CCD cameras now register the deviation of the reflected light from
the shutter location. The deviation depends on the ametropia. From that, an
integrated microcomputer calculates the ametropia in D, based on the
sphere, cylinder and cylinder axis position.
1 Measuring ocular / Patient eyepiece 4 Chin rest
2 Keratometer ring 5 Marking for the eye height
3 Pachycam camera glass cover
Keratometer
To determine the curvature of the cornea, a reflected image of the cornea
is captured by a camera sensor and is measured.
The reflection of test marks and of a ring is used as the reflected image.
This allows the central radii of the cornea to be determined.
Pachymeter
The pachymetry principle uses Scheimpflug images of the cornea, which
are analysed by a built-in computer.
600 Absolute data points are evaluated with the Scheimpflug image. The
measuring range lies on a 4 mm slit through the apex.
The slit light illuminates a sectional plane from the front surface of the cornea
to the back surface. The transparent cells of the cornea scatter the slit
light such that the sectional plane appears as if it were self-luminous.
This is captured at an angle of 45° through the pupil by a camera, whereby
the image plane of the camera is also tilted 45° to the optical axis of the
camera lens, in order to sharply focus the light-scattering cornea plane
onto the image plane of the camera (Scheimpflug image).
Thanks to this arrangement, sharp sectional images of the cornea can be attained.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36387 | Ophthalmic refractometer, manual |
A manually-operated ophthalmic device designed to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina); typically the measurements are made in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information the optometrist can calculate the lens prescription needed to correct the patient's refractive error. With advanced instruments the measurements are made automatically with printed verification.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HLQ | Keratoscope, Ac-Powered |
HKO | Refractometer, Ophthalmic |
MXK | Device,Analysis,Anterior Segment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K073508 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -10 and 70 Degrees Celsius |
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 12 Kilogram |
Depth: 530 Millimeter |
Width: 538 Millimeter |
Height: 265 Millimeter |
Device Record Status
a40ea847-b377-47c1-978d-43101bcca848
July 06, 2018
3
September 01, 2016
July 06, 2018
3
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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